PB2109: REALMIND: A PROSPECTIVE, MULTICENTER, OBSERVATIONAL STUDY OF PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA STARTING SECOND/THIRD-LINE THERAPY AND NOT RECEIVING A STEM CELL TRANSPLANT
Authors: C. R. Flowers, J. M. Burke, M. Vukcevic, S. Snodgrass, K. Saverno, M. A. A. Lumiqued
Journal: HemaSphere (2022)

Background: Although R-CHOP in the first-line (1L) setting is curative for >60% of diffuse large B-cell lymphoma (DLBCL) patients, up to 40% will have relapsed/refractory (R/R) disease. Treatment options in the R/R setting for patients not eligible for autologous stem cell transplant (ASCT) include the anti-CD19 antibody tafasitamab plus lenalidomide, the anti-CD79b Ab-drug conjugate polatuzumab plus bendamustine plus rituximab, the anti-CD19 antibody-drug conjugate loncastuximab tesirine, the nuclear export inhibitor selinexor, and CD19 CAR T-cell therapies. Sequencing these options and identifying the optimal choice of treatment for individual patients can be challenging for practicing oncologists. Aims: realMIND (NCT04981795) will assess real-world treatment patterns, effectiveness measures, and patient-reported outcomes among patients in the United States (US) with R/R DLBCL not receiving ASCT. Methods: This Phase IV, prospective, multicenter, observational study is enrolling patients ≥18 years old with histologically confirmed DLBCL at initial diagnosis and R/R status after at least one prior systemic therapy, including ASCT. Sites are being targeted across the US with the intent of enrolling a diverse patient population representative of the underlying US population with R/R DLBCL regarding age, ethnicity, and race. Patients may enroll in the study (a) after completing 1L therapy and before starting second-line (2L) therapy, (b) within 30 days after starting 2L therapy, and (c) after completing 2L and before receiving third-line therapy (Figure). Patients who are eligible or candidates for ASCT may be enrolled in the study if they are not receiving ASCT at the time of enrollment. Patient history data on therapies received before study enrollment will be collected from patient records; data generated from time of enrollment onwards will be collected prospectively. Real-world effectiveness measures will include complete and objective response rate, duration of response, event-free survival, and overall survival; safety endpoints include serious adverse events and adverse events leading to treatment discontinuation, interruption, or dose modification. Patient-reported outcomes will include general and lymphoma-specific measures of health-related quality of life assessed by the EORTC Quality of Life Questionnaire-Core 30 and Functional Assessment of Cancer Therapy – Lymphoma, and work productivity by the Work Productivity and Activity Impairment Questionnaire. The end of the study is expected to occur approximately 79 months after the first patient is enrolled to ensure a minimum of 24 months’ follow-up after last enrollment. All analyses will be descriptive, and time-to-event analyses will be conducted using Kaplan–Meier methods. realMIND is actively recruiting. Results: Results for this study are not yet available: outcome data as described above will be presented in due course. Image:Summary/Conclusion: realMIND will provide further understanding and characterization of the R/R DLBCL patient journey with respect to treatment patterns, clinical and patient-reported outcomes. The study population will reflect a representative distribution of patients within the US, facilitating investigation of outcomes in a patient population reflecting real-world clinical practice and producing data to support healthcare decision-making.